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Sponsored by: |
Teva Pharmaceuticals USA |
---|---|
Information provided by: | Teva Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00834990 |
This study will compare the relative bioavailability of 500 mg Divalproex Sodium Delayed-Release Tablets with that of 500 mg Depakote® Tablets following a single oral dose (1 x 500 mg tablets) in healthy subjects under non-fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: divalproex sodium Drug: Depakote® |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Relative Bioavailability Study of 500 mg Divalproex Sodium Delayed-Release Tablets Under Non-Fasting Conditions |
Enrollment: | 24 |
Study Start Date: | September 2003 |
Study Completion Date: | September 2003 |
Primary Completion Date: | September 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: divalproex sodium
delayed-release 500 mg tablet
|
2: Active Comparator |
Drug: Depakote®
delayed-release 500 mg tablet
|
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.
The screening clinical laboratory procedures will include:
If female and:
Exclusion Criteria
United States, North Dakota | |
PRACS Institute Ltd. | |
Fargo, North Dakota, United States, 58104 |
Principal Investigator: | James D Carlson, Pharm. D. | PRACS Institute |
Study ID Numbers: | R03-593 |
Study First Received: | January 30, 2009 |
Last Updated: | January 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00834990 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bioequivalence Healthy Subjects |
Neurotransmitter Agents Tranquilizing Agents Psychotropic Drugs Central Nervous System Depressants |
Healthy Antimanic Agents Valproic Acid Anticonvulsants |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Enzyme Inhibitors |
Antimanic Agents Valproic Acid Pharmacologic Actions Therapeutic Uses GABA Agents Central Nervous System Agents Anticonvulsants |